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Aseptic Process Engineer Jobs in New York (NOW HIRING)

Technical Trainer

Morris Plains, NJ · On-site

$84K - $126K/yr

  • Medical

  • Retirement

  • PTO

This role provides technical training to the manufacturing cell processors, aseptic trainers, media ... Salary Range $84,000.00 - $126,000.00 Skills Desired Change Control, Chemical Engineering ...

QA Shop Floor Specialist II

Raritan, NJ · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Support processes that include aseptic process simulations, Commercial & clinical manufacturing ... Bachelors degree required in Life Sciences or Engineering. * 0-2+ years Biotech/Pharmaceutical ...

QA, Shop Floor Specialist II

Raritan, NJ · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Support processes that include aseptic process simulations, Commercial & clinical manufacturing ... Bachelor's degree required in Life Sciences or Engineering. * 0-2+ years Biotech/Pharmaceutical ...

QA, Shop Floor Specialist I/II

Raritan, NJ · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Support processes that include aseptic process simulations, Commercial & clinical manufacturing ... Bachelor's degree required in Life Sciences or Engineering. * 0-2+ years Biotech/Pharmaceutical ...

Manager, Production

Parsippany, NJ · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Ensure all manufacturing activities comply with GMP, aseptic processing requirements, and site ... Engineering / Maintenance * MS&T (Manufacturing Science & Technology) * Supply Chain / Planning

Manager, Production

Parsippany, NJ · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Ensure all manufacturing activities comply with GMP, aseptic processing requirements, and site ... Engineering / Maintenance * MS&T (Manufacturing Science & Technology) * Supply Chain / Planning

Sr. Radiochemist

Totowa, NJ · On-site

$90K - $100K/yr

Qualifications Degree in chemistry, engineering or natural sciences preferred but will entertain ... Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment ...

MSAT Support

Allendale, NJ

$34/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Create and revise Aseptic Process Simulation (APS) documentation (Protocols, MBRs, eBRs, Risk ... Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical ...

Sr. Radiochemist

Totowa, NJ · On-site

$90K - $100K/yr

Degree in chemistry, engineering or natural sciences preferred but will entertain applicants with ... Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment ...

Showing results 21-40

Aseptic Process Engineer information

What is an aseptic process engineer?

Aseptic process engineers are professionals who design, develop, and maintain sterile manufacturing systems, primarily in the pharmaceutical, biotechnology, and food industries. Their main responsibility is to ensure that products are produced in a contamination-free environment, using processes that prevent the introduction of microorganisms. This involves overseeing the design of cleanrooms, validating equipment, developing standard operating procedures, and ensuring regulatory compliance. Aseptic process engineers work closely with quality assurance teams to maintain high standards of product safety and efficacy. Their expertise is crucial for industries where product sterility is critical to consumer safety.

What are the key skills and qualifications needed to thrive as an aseptic process engineer, and why are they important?

Aseptic Process Engineers need a strong background in chemical, mechanical, or biomedical engineering, along with experience in aseptic manufacturing environments and a solid understanding of GMP regulations. Familiarity with process automation systems, sterilization equipment, and industry certifications such as Six Sigma or Lean Manufacturing are often required. Attention to detail, strong problem-solving abilities, and effective communication are vital soft skills for ensuring product quality and process efficiency. These skills are crucial for maintaining sterile conditions, regulatory compliance, and the safe production of pharmaceuticals or biotechnology products.

What are some common challenges faced by aseptic process engineers, and how can they be addressed?

Aseptic Process Engineers often encounter challenges such as maintaining strict sterility standards, troubleshooting equipment issues, and ensuring compliance with changing regulatory requirements. Addressing these challenges requires strong attention to detail, proactive communication with cross-functional teams, and staying current with industry best practices and regulations. Collaborating closely with quality assurance, production, and maintenance teams helps to identify and resolve issues quickly, ensuring that processes remain efficient and compliant.

What is the difference between Aseptic Process Engineer vs Pharmaceutical Manufacturing Technician?

AspectAseptic Process EngineerPharmaceutical Manufacturing Technician
CredentialsBachelor's degree in engineering, life sciences, or related field; GMP trainingHigh school diploma or associate degree; GMP training often required
Work EnvironmentCleanroom, sterile environments, manufacturing facilitiesManufacturing floors, production areas, sometimes cleanrooms
Industry UsageDesign, optimize, and validate aseptic processes in pharmaOperate equipment, assemble products, support manufacturing

The Aseptic Process Engineer focuses on designing and validating sterile manufacturing processes, requiring specialized engineering knowledge. In contrast, the Pharmaceutical Manufacturing Technician handles day-to-day production tasks, often with less formal education but essential for maintaining manufacturing flow. Both roles are vital in pharmaceutical production but differ in responsibilities and qualifications.

What job categories do people searching Aseptic Process Engineer jobs in New York look for?

The top searched job categories for Aseptic Process Engineer jobs in New York are:

What cities in New York are hiring for Aseptic Process Engineer jobs?

Cities in New York with the most Aseptic Process Engineer job openings:

Change Control Engineer - Senior CQV Specialist (Remote)

Wood Plc

Newark, NJ • Remote

Full-time

Re-posted 27 days ago


Job description

Overview / Responsibilities

Wood PLC, on a global scale, serves the Pharma-Bio, Oil & Gas, Federal, Infrastructure, Manufacturing, Mining, and Power Industries. Our Philadelphia office has become the center of excellence for our global Life Sciences network. It provides process engineering, process design, and commissioning - qualification - validation (CQV) services to pharmaceutical/biotechnology clients worldwide. For projects of every scale, we provide services that support a facility's entire life cycle to bring life-saving therapeutics from concept through fruition. Learning from our team of industry-leading experts in facility design, regulatory standards, and project management will pay dividends toward your future engineering career.

Our CQV group at Wood is growing and we are adding to our well respected and established team of Change Control Engineer - Senior Specialists. We are looking for candidates experienced in manufacturing, process, engineering, commissioning, qualification and/or validation within the pharmaceuticals, biopharmaceuticals, vaccines, and aseptic processing areas. If you are interested in working with a global leader in life sciences and possess the skill and drive to flourish in a dynamic and exciting environment, apply today!

This position is 100% remote with no travel to the client. Must be physically located within the United States. Must have reliable a high-speed internet connection. Must have excellent communication (both written and verbal), organization, and planning skills in addition to BioPharma facilities and unit operations knowledge with an emphasis on equipment change control.

Key Responsibilities

  • Preparation and authoring of all change control deliverables.
  • Ability to carry out, complete and document change control process.
  • Ability to work independently, under the direction of the client and with client-side stakeholders.
  • Ability to read, understand and GMP review all BioPharma documentation including P&IDs, TOPs, vendor specifications, Maintenance records, etc.
  • Manage punch lists and effectively execute change control.
  • Author, consult with stakeholders, and communicate with vendors.
  • Effectively interfacing and communicating with 3rd parties, client and Wood team.
  • Ability to multi-task and adjust priorities to meet change control timelines.
  • Able to complete work 100% remote is essential.
Skills / Qualifications

Skills/Qualifications

  • Degree in engineering (preferably) or life sciences or suitable industry experience.
  • Minimum of 5+ years of direct experience in CQV and/or Engineering.
  • Experience in the equipment documentation and the change control process.
  • Strong and clear communication skills, both written and verbal.
  • Ability to effectively interface with Wood management, co-workers, clients, vendors and subcontractors.
  • Understanding with advanced knowledge of common unit operations and processes used in biopharma/pharmaceutical manufacturing.
  • Thorough knowledge of cGMPs as related to the pharmaceutical industry.
  • Strong computer skills.
  • Customer service oriented.
  • Ability to understand the challenges of managing a schedule of multiple change controls and with the drive to complete them successfully.
  • Ability to work safely and keep the safety of others in mind.
  • Ability to recognize hazards and communicate these to the appropriate individuals.

Physical Requirements

  • While performing the duties of this job the employee is frequently required to: type, sit, and stand and requires computer display close vision work.
Company Overview

Wood is a global leader in engineering and consultancy across energy and the built environment, helping to unlock solutions to some of the world's most critical challenges. We provide consulting, projects and operations solutions in more than 60 countries, employing around 40,000 people. www.woodplc.com

Diversity Statement

We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.

Employment Type: OTHER